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Senior Manager, GCP Quality

Posted on Apr 6, 2021 by CRISPR Therapeutics AG

Cambridge, MA 02138
Research
Immediate Start
Annual Salary
Full-Time


This individual will have primary responsibility for supporting the Head of GCLP Quality with GCP activities at CRISPR, its CROs, and Investigator Sites. The successful hire will ensure high quality execution of clinical trials from first in human through commercial marketing authorization. This person will interact with internal and external stakeholders and be the Quality Assurance representative to clinical teams. This individual will be hands on with internal and external partners. This is a high visibility position with great impact potential.


Responsibilities


Assist in the development, implementation, and maintenance of GCP Quality Systems and SOPs
Train and mentor staff on global GCP regulations and Guidelines
Actively participate in Clinical Operations meetings and provide timely updates to management
Conduct CRO and Investigator site monitoring; support inspection readiness initiatives
Identify Quality and Compliance related issues and implement practical solutions while ensuring timelines are maintained
Conduct QA oversight and audit of eTMFs
Lead/oversee consultant mediated audits; Develop, recommend, and follow up on corrective actions
Lead and manage GCP Inspections on behalf of CRISPR
Periodically report the state of GCP Quality and Compliance of clinical trials to CRISPR senior management
The candidate must be able to problem solve, communicate effectively, and trouble-shoot creatively


Minimum Qualifications


BS in Biological Sciences or related fields
Minimum 5 years of relevant industry experience in Sponsor companies, CROs, or GCP consulting
Direct experience in managing Health Authority GCP Inspections
Excellent communication, writing and presentation skills
Demonstrated ability to work independently and in a team environment and seek resources as necessary
Ability to assess complex issues, break down into components and propose viable solutions
Demonstrated ability to lead and organize team meetings
Ability to foster effective relationships with vendors, investigators and colleagues
Excellent knowledge of Global GCP regulations and industry standards
Proficiency in study monitoring activities
Knowledge of the infrastructure and operational characteristics of CROs and centralized services
Demonstrated effective time management skills
Must be willing to travel domestically and internationally up to 15-20%


Preferred Qualifications


MS or advanced degree in Biological Sciences or related fields
Five or more years in a QA GCP regulated role
Global trial management experience
Prior Clinical Monitoring and/or CRO experience
Knowledge of First in Human trial management
Experience with Cellular Therapy trial management




Reference: 1152693094

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